ProCell Surgical, Inc. received FDA approval for ProCell™ Surgical Sponge – Blood Recovery Unit on June 1st, 2020.
The ProCell™ Surgical Sponge – Blood Recovery Unit (ProCell™) is a device used to extract blood from surgical sponges, automating the manual hand-wringing process. Surgical sponges are placed into the ProCell™ unit, the blood is extracted and collected in a Reservoir. Blood is extracted using standard operating room vacuum suction and a piston mechanism. ProCell™ does not filter or otherwise process the blood collected from surgical sponges, but is used as a preliminary step in the process of intraoperative autotransfusion (IAT). It may be used in conjunction with standard IAT equipment prior to administering an autologous blood transfusion to the patient.
Designed for ease-of-use directly on the surgical instrument table, ProCell™ is disposable and can be used repeatedly during a surgical case, providing an alternative to other sponge-blood recovery methods.
Biocompatibility of the materials for the ProCell™ device was assessed and there were no biocompatibility risks associated with the materials tested. Red blood cell viability after collection using the Procell™ device has been determined to be in compliance with appropriate standards.
The FDA determined this device is substantially equivalent to the Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System (Pleur-Evac). Both are single case-use accessories to an Autotransfusion Apparatus that operate through a vacuum assist and do not process the collected blood.
ProCell™ is approved as an autotransfusion apparatus to collect and reinfuse blood lost by a patient due to surgery or trauma.
The autotransfusion of blood recovered from the operative field is contraindicated in the presence of bacterial contamination or malignancy. ProCell™ does not filter or otherwise process the blood collected in any way and must be used in conjunction with a hospital’s IAT equipment. Procell™ can be used up to 50 times during a single surgical case but cannot be reprocessed.